Endoscopy in Intraventricular LesionsNCT04569201
Endoscopic and Endoscopic-Assisted Microsurgery of Intraventricular Lesions
An observational study of Endoscopy in Intraventricular Lesions, run by Assiut University.
Trial summary
Assess the efficacy of the endoscope as a single tool or as an adjuvant tool to the microscope in intraventricular procedures. Evaluate the limitations of the endoscope in these procedures. Review the outcome of endoscopic and/or endoscopic assisted microsurgical intraventricular procedures. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Endoscopy in Intraventricular Lesions
- What is being tested?
- Endoscope
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2020to 1 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: PAtients with intraventricular lesions, presented to The Neurosurgery Department, At Assiut University Hospital in Assiut, Egypt
Who may be able to join
- Intraventricular arachnoid cysts
- Intraventricular colloid cysts
- Intraventricular tumors.
Who cannot join
- Intraventricular lesions extending outside the ventricle (exception to arachnoid cysts)
- Patients who are unfit for any neurosurgical interventions.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Endoscopic and Endoscopic-Assisted Microsurgery of Intraventricular Lesions: Efficacy of Technique and Outcome Assessment
- Assess the efficacy of the endoscope as a single tool or as an adjuvant tool to the microscope in intraventricular procedures.
- Evaluate the limitations of the endoscope in these procedures.
- Review the outcome of endoscopic and/or endoscopic assisted microsurgical intraventricular procedures.
- Achieve a verdict in the long-standing controversy about the most effective, least invasive, and optimal way to resect intraventricular lesions, can the endoscope rival the surgical microscope?
Read the detailed description
Lesions within the ventricular system present a challenge to neurosurgeons (1). Their deep location and proximity to eloquent neurovascular anatomy complicate surgical approach and resection (2). Microsurgery remains the gold standard for the treatment of intraventricular tumors, but microsurgical approaches are not without limitations (3). With the use of the operative microscope, most lesions of the lateral and third ventricles are accessed by a craniotomy and either a transcortical or interhemispheric transcallosal approach. These approaches are associated with brain retraction that can result in seizures, focal neurologic deficits, and cognitive impairment (1). Also with standard microsurgical techniques, complete resection is sometimes not achieved either because of nonvisualization of hidden parts of the tumor or requirement of significant retraction of the neurovascular structures which is potentially hazardous (4). The addition of the endoscope for resection of intraventricular lesions has been described and represents a minimally invasive approach that limits brain retraction and provides direct lesion visualization (1,5,6). The recent development of endoscopic instrumentation has greatly enhanced microsurgical access to the ventricular system and would allow enhanced microsurgical access, minimize the size of the transcortical corridor, and reduce brain retraction during removal of challenging intraventricular lesions performed with the surgical microscope (7). The application of the endoscope can be used in the treatment of intraventricular lesions as arachnoid cyst with intraventricular extensions, colloid cysts, biopsies and intraventricular brain tumor removal (8). Reestablishment of CSF communication pathways is also possible endoscopically when patients develop obstructive hydrocephalus due to their intraventricular pathology (1). The biggest issues when it comes to a pure endoscopic approach concern the size and extent of the lesion, possibility of complete cure or at least long-term control of the disease, and the presence of remnants that were not completely excised (8) , However, The desire for a less invasive technique and an effective surgical approach to intraventricular pathology has directed the attention of many in the neurosurgical community towards the introduction of the endoscope as an adjuvant to or even a replacement for the microscope in intraventricular surgery (5) and consequently, neuroendoscopy has grown rapidly in the last 25 years as a therapeutic modality in the treatment of intraventricular pathologies (9,10).
- Conditions
- Endoscopy in Intraventricular Lesions
- Being tested
- Endoscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndoscopeProcedure or surgery
The use of the neuro endoscope in excision of intraventricular lesions either alone or in assistance of the surgical microscope
What is being measured
The primary outcome is the main question the study is designed to answer.
Early Clinical outcome using Glasgow Outcome Scale
Assessment of the post operative mortality and morbidity using:
Glasgow Outcome Scale:
- Death:Self-explanatory
- Persistent vegetative state: Coma or severe deficit rendering the patient totally dependent
- Severe disability: Significant neurological deficit interfering with daily activities or prevents return to employment
- Moderate disability:Minor neurological deficit not interfering with daily functioning or work
- Good recovery:Returned to the original functional level with no deficit
Measured: Early outcome: 24 hours post-operatively.
Early Clinical outcome using Modified Rankin Scale
The Modified Rankin Scale (mRS) is used to measure the degree of disability in patients, as follows:
- 0: No symptoms at all
- 1: No significant disability despite symptoms; able to carry out all usual duties and activities
- 2: Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance
- 3: Moderate disability; requiring some help, but able to walk without assistance
- 4: Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance
- 5: Severe disability; bedridden, incontinent and requiring constant nursing care and attention
- 6: Dead
Measured: Within 6 weeks after surgery.
Late outcome assessment
Within six months, assessment of the performance of the patient with modified rankin scale.
Measured: within 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2020
- Study start1 Nov 2020 (estimated)
- Primary completion1 Nov 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Endoscopy in Intraventricular LesionsStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nour Imam, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04569201
- Sponsor's protocol ID
- Intraventricular Endoscopy
- Status last verified
- Sep 2020
- First submitted
- 21 Sep 2020
- Last updated
- 29 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
Publications
Nduom EK, Sribnick EA, Ormond DR, Hadjipanayis CG. Neuroendoscopic Resection of Intraventricular Tumors and Cysts through a Working Channel with a Variable Aspiration Tissue Resector: A Feasibility and Safety Study. Minim Invasive Surg. 2013;2013:471805. doi: 10.1155/2013/471805. Epub 2013 Jun 13.
PubMed 23844287Yasargil MG, Abdulrauf SI. Surgery of intraventricular tumors. Neurosurgery. 2008 Jun;62(6 Suppl 3):1029-40; discussion 1040-1. doi: 10.1227/01.neu.0000333768.12951.9a.
PubMed 18695523Barber SM, Rangel-Castilla L, Baskin D. Neuroendoscopic resection of intraventricular tumors: a systematic outcomes analysis. Minim Invasive Surg. 2013;2013:898753. doi: 10.1155/2013/898753. Epub 2013 Sep 26.
PubMed 24191196Singh I, Rohilla S, Kumar P, Krishana G. Combined microsurgical and endoscopic technique for removal of extensive intracranial epidermoids. Surg Neurol Int. 2018 Feb 14;9:36. doi: 10.4103/sni.sni_392_17. eCollection 2018.
PubMed 29527394Cappabianca P, Cinalli G, Gangemi M, Brunori A, Cavallo LM, de Divitiis E, Decq P, Delitala A, Di Rocco F, Frazee J, Godano U, Grotenhuis A, Longatti P, Mascari C, Nishihara T, Oi S, Rekate H, Schroeder HW, Souweidane MM, Spennato P, Tamburrini G, Teo C, Warf B, Zymberg ST. Application of neuroendoscopy to intraventricular lesions. Neurosurgery. 2008 Feb;62 Suppl 2:575-97; discussion 597-8. doi: 10.1227/01.neu.0000316262.74843.dd.
PubMed 18596446Souweidane MM, Luther N. Endoscopic resection of solid intraventricular brain tumors. J Neurosurg. 2006 Aug;105(2):271-8. doi: 10.3171/jns.2006.105.2.271.
PubMed 17219833Harris AE, Hadjipanayis CG, Lunsford LD, Lunsford AK, Kassam AB. Microsurgical removal of intraventricular lesions using endoscopic visualization and stereotactic guidance. Neurosurgery. 2005 Jan;56(1 Suppl):125-32; discussion 125-32. doi: 10.1227/01.neu.0000146227.75138.08.
PubMed 15799800Brunori A, de Falco R, Delitala A, Schaller K, Schonauer C. Tailoring Endoscopic Approach to Colloid Cysts of the Third Ventricle: A Multicenter Experience. World Neurosurg. 2018 Sep;117:e457-e464. doi: 10.1016/j.wneu.2018.06.051. Epub 2018 Jun 26.
PubMed 29959067Yadav YR, Parihar V, Sinha M, Jain N. Endoscopic treatment of the suprasellar arachnoid cyst. Neurol India. 2010 Mar-Apr;58(2):280-3. doi: 10.4103/0028-3886.63772.
PubMed 20508350Romano A, Chibbaro S, Marsella M, Oretti G, Spiriev T, Iaccarino C, Servadei F. Combined endoscopic transsphenoidal-transventricular approach for resection of a giant pituitary macroadenoma. World Neurosurg. 2010 Jul;74(1):161-4. doi: 10.1016/j.wneu.2010.02.024.
PubMed 21300008
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic and Endoscopic-Assisted Microsurgery of Intraventricular Lesions: Efficacy of Technique and Outcome Assessment
- ClinicalTrials.gov ID
- NCT04569201
- Acronym / sponsor ID
- Intraventricular Endoscopy
- Conditions
- Endoscopy in Intraventricular Lesions
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2020 (estimated)
- Primary completion
- 1 Nov 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 29 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Assess the efficacy of the endoscope as a single tool or as an adjuvant tool to the microscope in intraventricular procedures.
- Evaluate the limitations of the endoscope in these procedures.
- Review the outcome of endoscopic and/or endoscopic assisted microsurgical intraventricular procedures.
- Achieve a verdict in the long-standing controversy about the most effective, least invasive, and optimal way to resect intraventricular lesions, can the endoscope rival the surgical microscope?
Detailed description
Lesions within the ventricular system present a challenge to neurosurgeons (1). Their deep location and proximity to eloquent neurovascular anatomy complicate surgical approach and resection (2). Microsurgery remains the gold standard for the treatment of intraventricular tumors, but microsurgical approaches are not without limitations (3). With the use of the operative microscope, most lesions of the lateral and third ventricles are accessed by a craniotomy and either a transcortical or interhemispheric transcallosal approach. These approaches are associated with brain retraction that can result in seizures, focal neurologic deficits, and cognitive impairment (1). Also with standard microsurgical techniques, complete resection is sometimes not achieved either because of nonvisualization of hidden parts of the tumor or requirement of significant retraction of the neurovascular structures which is potentially hazardous (4). The addition of the endoscope for resection of intraventricular lesions has been described and represents a minimally invasive approach that limits brain retraction and provides direct lesion visualization (1,5,6). The recent development of endoscopic instrumentation has greatly enhanced microsurgical access to the ventricular system and would allow enhanced microsurgical access, minimize the size of the transcortical corridor, and reduce brain retraction during removal of challenging intraventricular lesions performed with the surgical microscope (7). The application of the endoscope can be used in the treatment of intraventricular lesions as arachnoid cyst with intraventricular extensions, colloid cysts, biopsies and intraventricular brain tumor removal (8). Reestablishment of CSF communication pathways is also possible endoscopically when patients develop obstructive hydrocephalus due to their intraventricular pathology (1). The biggest issues when it comes to a pure endoscopic approach concern the size and extent of the lesion, possibility of complete cure or at least long-term control of the disease, and the presence of remnants that were not completely excised (8) , However, The desire for a less invasive technique and an effective surgical approach to intraventricular pathology has directed the attention of many in the neurosurgical community towards the introduction of the endoscope as an adjuvant to or even a replacement for the microscope in intraventricular surgery (5) and consequently, neuroendoscopy has grown rapidly in the last 25 years as a therapeutic modality in the treatment of intraventricular pathologies (9,10).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- PAtients with intraventricular lesions, presented to The Neurosurgery Department, At Assiut University Hospital in Assiut, Egypt
Key inclusion criteria (3 listed)
- Intraventricular arachnoid cysts
- Intraventricular colloid cysts
- Intraventricular tumors.
Key exclusion criteria (2 listed)
- Intraventricular lesions extending outside the ventricle (exception to arachnoid cysts)
- Patients who are unfit for any neurosurgical interventions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EndoscopeThe use of the neuro endoscope in excision of intraventricular lesions either alone or in assistance of the surgical microscope | Procedure or surgery | – |
Primary outcome
Early Clinical outcome using Glasgow Outcome Scale
Time frame: Early outcome: 24 hours post-operatively.
Assessment of the post operative mortality and morbidity using: Glasgow Outcome Scale: 1. Death:Self-explanatory 2. Persistent vegetative state: Coma or severe deficit rendering the patient totally dependent 3. Severe disability: Significant neurological deficit interfering with daily activities or prevents return to employment 4. Moderate disability:Minor neurological deficit not interfering with daily functioning or work 5. Good recovery:Returned to the original functional level with no deficit
Early Clinical outcome using Modified Rankin Scale
Time frame: Within 6 weeks after surgery.
The Modified Rankin Scale (mRS) is used to measure the degree of disability in patients, as follows: * 0: No symptoms at all * 1: No significant disability despite symptoms; able to carry out all usual duties and activities * 2: Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance * 3: Moderate disability; requiring some help, but able to walk without assistance * 4: Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance * 5: Severe disability; bedridden, incontinent and requiring constant nursing care and attention * 6: Dead
Late outcome assessment
Time frame: within 6 months after surgery
Within six months, assessment of the performance of the patient with modified rankin scale.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2020.
- Background: PubMed 23844287Nduom EK, Sribnick EA, Ormond DR, Hadjipanayis CG. Neuroendoscopic Resection of Intraventricular Tumors and Cysts through a Working Channel with a Variable Aspiration Tissue Resector: A Feasibility and Safety Study. Minim Invasive Surg. 2013;2013:471805. doi: 10.1155/2013/471805. Epub 2013 Jun 13.
- Background: PubMed 18695523Yasargil MG, Abdulrauf SI. Surgery of intraventricular tumors. Neurosurgery. 2008 Jun;62(6 Suppl 3):1029-40; discussion 1040-1. doi: 10.1227/01.neu.0000333768.12951.9a.
- Background: PubMed 24191196Barber SM, Rangel-Castilla L, Baskin D. Neuroendoscopic resection of intraventricular tumors: a systematic outcomes analysis. Minim Invasive Surg. 2013;2013:898753. doi: 10.1155/2013/898753. Epub 2013 Sep 26.
- Background: PubMed 29527394Singh I, Rohilla S, Kumar P, Krishana G. Combined microsurgical and endoscopic technique for removal of extensive intracranial epidermoids. Surg Neurol Int. 2018 Feb 14;9:36. doi: 10.4103/sni.sni_392_17. eCollection 2018.
- Background: PubMed 18596446Cappabianca P, Cinalli G, Gangemi M, Brunori A, Cavallo LM, de Divitiis E, Decq P, Delitala A, Di Rocco F, Frazee J, Godano U, Grotenhuis A, Longatti P, Mascari C, Nishihara T, Oi S, Rekate H, Schroeder HW, Souweidane MM, Spennato P, Tamburrini G, Teo C, Warf B, Zymberg ST. Application of neuroendoscopy to intraventricular lesions. Neurosurgery. 2008 Feb;62 Suppl 2:575-97; discussion 597-8. doi: 10.1227/01.neu.0000316262.74843.dd.
- Background: PubMed 17219833Souweidane MM, Luther N. Endoscopic resection of solid intraventricular brain tumors. J Neurosurg. 2006 Aug;105(2):271-8. doi: 10.3171/jns.2006.105.2.271.
- Background: PubMed 15799800Harris AE, Hadjipanayis CG, Lunsford LD, Lunsford AK, Kassam AB. Microsurgical removal of intraventricular lesions using endoscopic visualization and stereotactic guidance. Neurosurgery. 2005 Jan;56(1 Suppl):125-32; discussion 125-32. doi: 10.1227/01.neu.0000146227.75138.08.
- Background: PubMed 29959067Brunori A, de Falco R, Delitala A, Schaller K, Schonauer C. Tailoring Endoscopic Approach to Colloid Cysts of the Third Ventricle: A Multicenter Experience. World Neurosurg. 2018 Sep;117:e457-e464. doi: 10.1016/j.wneu.2018.06.051. Epub 2018 Jun 26.
- Background: PubMed 20508350Yadav YR, Parihar V, Sinha M, Jain N. Endoscopic treatment of the suprasellar arachnoid cyst. Neurol India. 2010 Mar-Apr;58(2):280-3. doi: 10.4103/0028-3886.63772.
- Background: PubMed 21300008Romano A, Chibbaro S, Marsella M, Oretti G, Spiriev T, Iaccarino C, Servadei F. Combined endoscopic transsphenoidal-transventricular approach for resection of a giant pituitary macroadenoma. World Neurosurg. 2010 Jul;74(1):161-4. doi: 10.1016/j.wneu.2010.02.024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Endoscopy in Intraventricular Lesions, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nour Eldin H. M. K. Imam, Masters Degree in Neurosurgery (+201099855603, nourimam@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early Clinical outcome using Glasgow Outcome Scale (time frame: Early outcome: 24 hours post-operatively.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04569201, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2020.